| Class 2 Device Recall Covidien Surgiwand" II Suction and Irrigation Device | |
Date Initiated by Firm | March 05, 2021 |
Create Date | April 12, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1411-2021 |
Recall Event ID |
87542 |
510(K)Number | K961771 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22
Product Number/CFN: 178083, 178093, 178094 |
Code Information |
UDI-Device Identifier (GTIN/UPN): 10884523000887, 20884523000884 UDI-Device Identifier (GTIN/UPN): 10884523000900, 20884523000907 UDI-Device Identifier (GTIN/UPN): 10884523000917, 20884523000914 |
Recalling Firm/ Manufacturer |
Covidien 201 Sabanetas Industrial Park Building 911-67 Ponce PR 00716
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For Additional Information Contact | Bryan Dannettell 303-530-6383 |
Manufacturer Reason for Recall | Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector. |
FDA Determined Cause 2 | Process design |
Action | On 3/10/2021, Medtronic issued an Urgent Medical Device Recall notices to customers. All consignees were notified by letter delivered via Federal Express and/or certified mail. The letter informs customers of the recall of specific item codes and production lots of Covidien Surgiwand" II Suction and Irrigation Device following reports from customers of foreign particles in the device tubing. |
Quantity in Commerce | 59,828 devices |
Distribution | Domestic: AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, UT, WA, WI, WV. Foreign: Canada, Japan, Taiwan, Australia, New Zealand, Indonesia, Thailand, Singapore, Malaysia, Philippines, Bahamas, Brazil, Chile, El Salvador, Guatemala, Jamaica, Mexico, Panama, Peru, Puerto Rico, Trinidad And Tobago, Austria, Belgium, Bosnia And Herzegovina, Canary Islands, Cyprus, Denmark, Equatorial Guinea, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Kosovo, Kuwait, Lebanon, Mauritius, Netherlands, Norway, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, Spain, Swaziland, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = GEI
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